Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Case study: EYLEA® - A new drug from Bayer Healthcare and pricing under the conditions of AMNOG

Ellen Thom (Abschlußjahr: 2012)

Language: German

Using the example of Eylea®, a new drug from Bayer HealthCare for the treatment of wet agerelated macular degeneration (wAMD), it is demonstrated how the legal regulations in Germany, particularly after the introduction of the AMNOG (Arzneimittelmarkt-Neuordnungsgesetz) with early benefit assessment and rebate negotiations (Erstattungsbeträge), impact on drug pricing.

Currently, for the treatment of wAMD only one comparable drug is approved, Lucentis® from Novartis, and for cost reasons Avastin® from Roche is used off-label. In addition, a vial of Lucentis® is often used contrary to the prescribing information for more than one treatment (Auseinzelung) and is injected not according to clinical studies in monthly intervals (continuously), but "as needed" (discontinuously). Numerous complications have arisen in the past out of this context.

Against this background possible options for Bayer to launch Eylea® in Germany are discussed. A key parameter here is the determination of the added value in the early benefit assessment depending on the specified appropriate comparator. For the choice of the introductory price and for the price/rebate negotiations with the National Association of Sick Funds and Health Insurances the price elasticity of demand on the German market as well as international dependencies (e.g. reference price effects) are important.

Pages: 95,
no Annexes